We are very pleased to welcome our new Head of Regulatory to the Congenius team!
Richie Christian joins Congenius with more than 10 years of progressive experience in regulatory affairs across medical devices and digital health, including more than 6 years in leadership roles building and scaling regulatory functions for both medical device companies and service providers. As an RAC-certified professional, he brings robust expertise in FDA requirements, EU MDR, and emerging technologies including AI/ML SaMD and cybersecurity compliance.
Having held cross-functional roles in New Zealand and Switzerland, Richie has a proven track record in leading regulatory strategy and securing market access across the US, EU, Canada, APAC, and Japan. He has successfully managed complex submissions and authority interactions – and built ISO 13485- and MDSAP-certified quality and regulatory systems from the ground up.
Most recently, Richie supported wega Informatik in Basel as a Senior Medical Device Consultant, delivering regulatory affairs and quality consulting services to medical device clients across Europe, with a focus on software-based devices, AI/ML technologies, and cybersecurity compliance. He also drove the expansion of service offerings, supported business development, and shared his knowledge as a speaker at leading industry events including the MedTech Summit 2024 and AI Act Summit 2024.
Congenius CEO Bastian Perroset commented, “Regulatory Affairs is a fundamental pillar of our service offering. Richie’s leadership experience, strategic mindset, and deep regulatory expertise perfectly place him to head up our evolving Regulatory department as we expand our capabilities to support our customers with RA for AI/ML and SaMD.”
Now based in Basel, Richie will be applying his strong background in regulatory leadership, quality management systems, and digital health innovation to regulatory projects for new and existing customers. He will also be a valued voice in our Congenius Academy – as an already-established industry contributor – having authored a chapter in Fundamentals of Medical Device Regulations and served as an exam writer and mentor for RAPS.
On joining Congenius he said, “This role offers an opportunity to apply my passion for building strong regulatory teams, enabling innovation, and delivering practical compliance solutions. I’m looking forward to developing the internal team and making a positive impact with our customers.”
Bastian added: “We are delighted to welcome Richie. I am confident that his ability to turn complex requirements into business-focused solutions will help drive the continued growth of our Regulatory team.”
To find out more about the services provided by the Regulatory team at Congenius, see here.
